A study to find how well Dazodalibep works and how safe it is in participants with Sjôgren`s Syndrome

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune System Phenomena [G13], Phenomena and Processes [G] - Immune system processes [G12], Diseases [C] - Immune System Diseases [C20]

Trial duration

16 May 2025 → ongoing

Decision date (initial)

2025-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Amgen Inc

External identifiers

EU CT number

2024-517513-32-00

ClinicalTrials.gov

NCT06747949

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

To evaluate the long-term safety and tolerability of dazodalibep.

Secondary objectives 2

1. 1. To assess the immunogenicity of long-term administration of dazodalibep in participants with SS.
2. 2.To characterize the PK of dazodalibep in participants with SS.

Conditions and MedDRA coding

Sjögren’s Syndrome

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002825-PIP01-20

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available on ClinicalTrials.gov and on the Amgen Clinical Trials portal.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1. Participant has provided informed consent before initiation of any study-specific activities/procedures.
2. 2. Must have been eligible to receive and have received investigational product (dazodalibep or placebo) and completed the study in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303). Note: Participants who prematurely discontinued investigational product are not eligible for this study.
3. 3. Be able to receive Dose 1 of this LTE study prior pivotal phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303). Note: Participants may be enrolled in the LTE after this window at the principal investigator’s discretion, but after consultation with the medical monitor.

Exclusion criteria 12

1. 201 Clinically significant active infection in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.
2. 202 Concurrent Clinical Study Experience Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.
3. 203 Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with investigational product administration.
4. 204 Planned surgeries or hospitalizations that, in the opinion of the investigator or the sponsor, would interfere with evaluation and interpretation of participant safety.
5. 205 Individuals who plan to receive live (attenuated) vaccine during the LTE study
6. 206 Female participants of childbearing potential unwilling to use protocol-specified method of contraception see (Section 11.5) during treatment and for an additional 12 weeks after the last dose of investigational product
7. 207 Female participants who are breastfeeding or who plan to breastfeed while on study through 12 weeks after the last dose of investigational product.
8. 208 Female participants planning to become pregnant or donate eggs while on study through 12 weeks after the last dose of investigational product.
9. 209 Female participants of childbearing potential with a positive pregnancy test assessed at day 1 by a highly sensitive urine pregnancy test.
10. 213 Participant has known sensitivity to any of the products or components to be administered during dosing.
11. 214 Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator’s knowledge.
12. 215 History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest (AESIs).

Secondary endpoints 2

1. 1.Development of positive anti-drug antibodies (ADAs) during the study.
2. 2. Plasma concentration of dazodalibep.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1730

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 10

Locations

12 EU/EEA countries · 84 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 88 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications